Compass Names New CEO, On Track For Phase 3 Study

Psychedelic drug company Compass Pathways plc (Nasdaq: CMPS) reported its financial results for the second quarter 2022 and gave an update on recent progress across its business. Compass delivered a net loss for the quarter of $21.0 million, or $0.50 loss per share (including non-cash share-based compensation expense of $3.2 million), compared with $17.5 million or $0.44 loss per share, during the same period in 2021 (including non-cash-share-based compensation expense of $1.9 million). The stock was trading higher in early trading rising by 3% to sell at roughly $16.65.

George Goldsmith, Executive Chairman of COMPASS Pathways, said, “Our decision to appoint Kabir Nath as our new CEO comes at the ideal time as we enter the late stages of COMP360 development and plan for regulatory approval and commercialization. Kabir’s dedication to our mission, extensive experience in leading the commercialization of innovative therapies and track record of successful strategic growth are precisely what COMPASS needs to advance our goal to bring COMP360 psilocybin therapy to the large number of patients who are not currently served by existing treatments. I look forward to working closely with him as Chairman.”

Compass reported that its research and development (R&D) expenses were $15.9 million for the quarter versus $11.4 million during the same period in 2021. The company said, “Of this increase, $0.2 million relates to an increase in external development expenses as we continue to investigate COMP360 psilocybin therapy in clinical and pre-clinical trials. A further $1.6 million and $0.9 million were attributable to personnel expenses and non-cash share-based compensation respectively, due to increased headcount. In addition, other expenses increased $1.9 million, which primarily related to an increase in external consulting expenses.”

On the plus side, the company won a recent patent challenge, and their Phase III clinical trial of the Comp360 psilocybin therapy to come later this year is piquing investors’ interest. 

Their total cash position is at $207.2 million, a $35 million decline from the end of 2021. Insiders hold nearly 50% of the shares of stocks, signaling confidence in the company’s prospects. It’s enough money to fund operations into 2024, according to Falvey during the investor call.

The company announced Nath as its new CEO on August 1. Nath has a solid background in medical technology and biopharma. He most recently was senior managing director of global pharmaceuticals at Otsuka, a biopharma company focused on research in neuroscience and treatments for adults with schizophrenia and major depressive disorder (MDD), bipolar disorder, and other neurological and neuropsychiatric conditions. Nath worked previously as president and CEO of Otsuka’s North America Pharmaceutical Business, and was called an “inspirational leader” by Goldsmith during the investor conference call. “We are thrilled to have him at the helm.”

As a result of the hiring of Nath, Goldsmith will serve as executive chairman until the end of 2022, and then as chairman beginning in 2023. 

“Following our end of phase II meeting with FDA, we have submitted our Phase 3 protocols and they are under review,” Goldsmith said in a press release announcing the investor call. “We are pleased with the progress and remain on track to start our phase III clinical program this year. We also continue to expand our clinical development of COMP360 therapy with the commencement of a phase II study in anorexia nervosa, a condition of significant unmet need for which there are no FDA approved pharmacological treatment options.”

On July 28, the company launched a multi-center, double-blind randomized controlled phase II clinical trial investigating the efficacy of COMP360 psilocybin, administered with psychological support, in people with anorexia nervosa. “Approximately 20 to 40% of deaths in anorexia. nervosa are thought to result from suicide, the highest suicide rate of any mental illness,” Goodwin said during the investor call.

The company cited other achievements for this year for their COMP360 psilocybin therapy for treatment resistant depression. Those include:

Holding end-of-phase II meeting with FDA and other regulators.

– Beginning phase III clinical program in treatment resistant depression.

Launching additional COMP360 clinical development programs.

Launching an investigator-led study in adults with autism spectrum disorder (ASD), the first ever mechanistic study of psilocybin in autistic adults, co-sponsored by Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King’s College London and South London and Maudsley NHS Foundation Trust.

– 10 granted patents issued to date covering composition, formulation and method of use.

– Identification of new potential novel drug candidates through the Compass Discovery Center.

Goldsmith also pointed to the company’s investor day, to be held on October 12, as a date for more investor details about the various clinical trials the company is working on, especially about the digital tools to be used for the anorexia work.

Dave Hodes

David Hodes is a business journalist based in the Washington D.C. metropolitan area. He has contributed feature articles to several cannabis and psychedelics publications, as well as general business/lifestyle publications, on a variety of topics. Hodes was selected as 2018 Journalist of the Year by Americans for Safe Access. He is a member of the National Press Club, and the deputy booking agent for the National Press Club Headliners Committee.

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